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FDA: Olumiant as first systemic medicine for adults with severe alopecia areata

The U.S. Food and Drug Administration ( FDA ) has approved Olumiant ( Baricitinib ), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata, available as 4-mg, 2-mg and 1-mg tablets.
The recommended dose is Olumiant 2-mg/day, with an increase to 4-mg/day if treatment response is inadequate.
For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4-mg/day.
Once an adequate response is achieved on 4-mg/day, the dosage is to be decreased to 2-mg/day.
Olumiant is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, Cyclosporine or other potent immunosuppressants.

Baricitinib is an oral JAK inhibitor.

The approval was based on BRAVE-AA1 and BRAVE-AA2 trials, the largest phase 3 AA clinical trial program completed to date, evaluating the efficacy and safety of Baricitinib in 1,200 adult patients with severe AA ( greater than or equal to 50% scalp hair loss as defined by a Severity of Alopecia Tool ( SALT ) score 50 or more ).
Across the studies at 36 weeks, 17-22% of patients taking Baricitinib 2-mg/day and 32-35% of patients taking Baricitinib 4-mg/day achieved 80% or more scalp hair coverage, compared to 3-5% taking placebo.
Additionally, 11-13% of patients taking Baricitinib 2-mg/day and 24-26% of patients taking Baricitinib 4-mg/day achieved 90% or more hair coverage, compared to 1-4% of patients taking placebo; results for Baricitinib 2-mg/day were not statistically significant under the multiplicity control plan for BRAVE-AA2.

Among patients with substantial eyebrow and eyelash hair loss at baseline, improvements in eyebrow and eyelash coverage were seen for patients taking Baricitinib 4-mg daily at 36 weeks.

The BRAVE-AA clinical program evaluated the safety profile of Baricitinib. Few patients discontinued treatment due to adverse events ( average of 2.2% across both studies ) in the 36-week placebo-controlled period and the majority of treatment-emergent adverse events were mild or moderate in severity.
The most commonly reported adverse reactions ( greater than or equal to 1% ) were upper respiratory tract infections, headache, acne, high cholesterol levels, increases in blood markers related to the muscle, urinary tract infections, elevated liver enzyme levels, inflammation of hair follicles, fatigue, lower respiratory tract infections, nausea, genital yeast infection, low red blood cell counts, low white blood cell counts, abdominal pain, shingles and weight increase.

The U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events ( MACE ) and thrombosis. ( Xagena )

Source: Eli Lilly, 2022